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FDA approves leukemia drug tested at Ohio State

Enlarge ImageRequest to buy this photoCourtney Hergesheimer | DispatchDennis Hickey, who was told he had terminal leukemia in 2000, exhausted approved drugs and entered the clinical trial for ibrutinib four years ago.

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Three pills a day have kept Dennis Hickey laughing, telling stories and loving his family long after doctors thought leukemia would take his life.

“I get to see the grandkids. I get to hold them and tell them how much we love them. I look forward to growing older,” said the 73-year-old Gahanna man, who was among the first patients to take ibrutinib, a cancer drug the Food and Drug Administration approved yesterday.

The drug, sold under the name Imbruvica, is widely expected to revolutionize care of chronic lymphocytic leukemia, the most-common type of the disease diagnosed in adults.

California-based Pharmacyclics makes the drug, which is expected to cost about $8,000 a month. The FDA previously approved its use for mantle-cell lymphoma, a type of non-Hodgkin’s lymphoma diagnosed in fewer than 5,000 Americans a year.

Each year, about 15,600 Americans learn they have CLL. The drug has been in an Ohio State University lab since its infancy in 2008. Dr. John C. Byrd, director of hematology at OSU’s Comprehensive Cancer Center, and fellow researchers have been integral in exploring the drug’s potential.

The work began with laboratory studies of the compound’s interaction with cancer cells and research into how it performed in animals.

Since 2009, Byrd and his colleagues have watched in awe as patients who were expected to die within months survived and lived good lives with few and manageable side effects for years. Common side effects include low platelet counts, fatigue, loose stools and musculoskeletal pain.

“It’s a pretty phenomenal feeling,” Byrd said of contributing to the speedy development of such an effective drug.

“On Monday in clinic, I saw about a half-dozen people and their spouses and children, and it’s humbling to realize that these people, that are right now back doing what they were doing before they had CLL, would not be with us.”

A study published in the New England Journal of Medicine last summer looked at 85 patients and found that 83 percent were alive two years and two months into the study. Study participants were patients who had tried other medications for CLL and had either not responded to the drugs or had relapsed.

About half were expected to die after six to nine months, Byrd said at the time of the study. Midway through a larger unpublished study of 391 cancer patients, researchers switched patients who weren’t assigned to take ibrutinib over to the drug, given its potential, he said.

Patients on the drug often show no outward signs of disease, Byrd said. They might even reach a point at which blood tests and physical exams reveal no cancer, although it remains in the bone marrow.

The drug inhibits a protein that feeds the growth of certain cancers. Researchers are testing the drug in a handful of other cancers and are exploring its potential to improve the immune system’s response to the disease, Byrd said.

Dr. Sanjay Yadav, a hematologist-oncologist who practices mostly at OhioHealth Doctors Hospital, said cancer specialists and their patients with CLL have been eagerly awaiting availability of the new drug.

“We oncologists have been waiting on this,” he said.

Ibrutinib is particularly promising for the approximately 1 in 10 CLL patients whose disease is particularly fast-moving and hard to treat, Yadav said.

“The most exciting thing is it’ll help patients who have the (poorest) prognosis,” he said.

Hickey, whose doctor told him he had terminal leukemia in 2000, exhausted all approved drugs years ago and entered into clinical trials of multiple medications at Ohio State. The aim was to keep the cancer out of his major organs.

Those drugs also stopped working. But the timing was right, and about four years ago, he started taking ibrutinib.

“After two weeks, not only was I feeling better, I wasn’t sick, nauseated and didn’t feel like I had chemo-head,” Hickey said. “I couldn’t believe it was happening.”

To this day, he has not experienced a relapse. “I just wish that everyone with this same type of cancer could receive this drug because it’s so effective.”

Wally Yocum of Marietta also is grateful for the new drug.

The 61-year-old found out he had leukemia in 2008. The initial routine treatment worked for about a year, he said. And the side effects were rough.

He was considering a stem-cell transplant (a high-risk option for CLL patients) when he enrolled in a study of ibrutinib.

“I feel fine. My blood counts have been fine for more than a year,” Yocum said. “It’s almost as if I don’t have anything.”

Yocum applauded approval of the drug for widespread use.

“The biggest thrill for me in doing this clinical trial is the knowledge that people won’t have to go through what I had to go through back in 2008.”